SAN DIEGO, Nov. 25, 2019 /PRNewswire/ -- DelMar
Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the
"Company"), a biopharmaceutical company focused on the development
of new solid tumor cancer therapies, today announced interim data
on its two Phase 2 trials of VAL-083, the Company's lead compound
for the treatment of glioblastoma multiforme (GBM). The data
were presented in two posters at the 2019 Society for NeuroOncology
Annual Meeting in Phoenix,
Ariz.
First-Line GBM
The first poster outlined the open-label, Phase 2 study of
VAL-083 as a first-line treatment in newly-diagnosed, unmethylated
GBM patients. This study has enrolled 23 out of a planned 30
patients as of the data cut-off date of November 2, 2019. For the 22 patients who had
completed at least one cycle of treatment as of that date, median
progression-free survival (PFS) with VAL-083 is currently 9.9
months (confidence interval, or CI 7.3-12.0 months). For the
18 patients initially receiving the intended treatment dose (30
mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median
PFS is currently 10.4 months (CI 6.0-12.0 months). While this is
not a head-to-head trial, historically, temozolomide (TMZ) has been
demonstrated to have 6.9 months PFS in unmethylated GBM patients.
Other doses were also examined as part of the dose escalation
aspect of the study, and all but the 20 mg/m2/day dose
also demonstrated superior PFS to the historical comparator. A
median of eight cycles of treatment has been received by all
patients who had either completed treatment or remain in active
treatment. Nine patients have received more than 10
cycles. This study is being conducted at Sun Yat-sen
University Cancer Center in China.
Recurrent GBM
The second poster outlined interim data from two groups of
patients receiving VAL-083 in the open-label, Phase 2 study in
recurrent and adjuvant unmethylated GBM settings. The
recurrent group is receiving second-line therapy with VAL-083
following TMZ failure. Sixty-two patients (out of a planned
83) have been enrolled as of the data cut-off of November 15, 2019, with 35 patients having
received an initial dose of 40 mg/m2/day and 27 (out of
a planned 48) having received an initial dose of 30
mg/m2/day (on days 1, 2 and 3 of a 21-day cycle). Median
overall survival (mOS) for the 60 patients who have completed at
least one cycle of treatment is currently 7.5 months (CI 6.0-11.5
months). For the 25 of those patients who initially received the
intended treatment dose of 30 mg/m2/day, mOS is
currently 10.6 months (CI 5.8-10.6 months). While this is not a
head-to-head trial, historically lomustine, which is the most
commonly used chemotherapy for these patients, has demonstrated a
mOS of 7.2 months.
The second arm of this study, in which patients receive VAL-083
as adjuvant therapy following treatment with radiation and TMZ, was
initiated in July 2019. As of the
data cut-off of November 15, 2019,
five patients (out of a planned 20) have been enrolled and all
patients remain alive on continued therapy. The study in
recurrent and adjuvant GBM is being conducted at M.D. Anderson
Cancer Center in Houston, Tex.
Similar to prior experience with VAL-083, myelosuppression has
been the most common adverse event observed. Four subjects have
experienced a serious adverse event (SAE) possibly related to
VAL-083 in the newly-diagnosed group, eleven subjects have
experienced a possibly drug-related SAE in the recurrent group, and
no patients have experienced a possibly drug-related SAE in the
adjuvant group as of the relevant data cut-off dates.
During a review of the data, which was conducted at the SNO
conference, Dr. David Reardon,
clinical director of the Center for Neuro-Oncology at the
Dana-Farber Cancer Institute, Professor of Medicine at the
Harvard Medical School and member of
DelMar's Scientific Advisory Board stated, "Putting it into the
perspective of what has benefitted our patients historically, which
has been a cytotoxic treatment approach like Delmar's VAL-083, we
have had other classes of anticancer therapies that have
unfortunately been quite disappointing. So, with VAL-083 we
have a mechanism of action that has a proven track record and a
rationale for why it may be superior to what we have
currently. All of those factors explain why it has been
challenging to move the bar in this disease. That said, I
think there is some reason to be hopeful that this has a likelihood
of further confirming the signals we have seen so far."
Dr. Nick Butowski, director of
translational research in neuro-oncology and a researcher at the
Brain Tumor Center and also a member of DelMar's Scientific
Advisory Board added, "Upon reviewing the analysis from both
studies, mechanistically, survival data-wise, imaging-wise, quality
of life and safety data are all very intriguing and exciting.
Obviously, we need to see the completed data and then move on to
the next steps."
Saiid Zarrabian, CEO of DelMar
Pharmaceuticals stated: "We continue to be encouraged with
the interim outcomes for both of our ongoing Phase 2 trials of
VAL-083 in GBM. Our first-line treatment study continues to
show outstanding results and we are particularly pleased to see
VAL-083 at the 30 mg dose currently showing a full three months
longer progression-free survival. This represents an
improvement of around 30% over temozolomide, the current standard
of care. We are also encouraged by the 30 mg dose in the
recurrent patient cohort, currently showing median overall survival
of more than three months or approximately a 30% improvement over
historical published results from the current standard of
care. We look forward to providing subsequent updates in 2020
at the American Academy of Cancer Research and American Society of
Clinical Oncology conferences."
The Company's current cash resources are expected to be sufficient
to fund the Company's planned operations into the fourth quarter of
calendar year 2020, and to allow for funding to top-line results
for our newly-diagnosed and recurrent setting studies, and for full
enrollment for the adjuvant study arm patients.
ABOUT DELMAR PHARMACEUTICALS
Located in San Diego,
California, DelMar is focused on the development and
commercialization of new therapies for cancer patients who have
limited or no treatment options. By focusing on understanding tumor
biology and mechanisms of treatment resistance, the Company
identifies biomarkers to personalize new therapies in indications
where patients are failing, or are unable to tolerate,
standard-of-care treatments.
The Company's current pipeline is based around VAL-083, a
"first-in-class", small-molecule chemotherapeutic with a novel
mechanism of action that has demonstrated clinical activity against
a range of cancers, including central nervous system, ovarian and
other solid tumors (e.g., NSCLC, bladder cancer, head & neck)
in U.S. clinical trials sponsored by the National Cancer Institute
(NCI). Based on DelMar's internal research programs and these prior
NCI-sponsored clinical studies, the Company is conducting clinical
trials to support the development and commercialization of VAL-083
to solve significant unmet medical needs.
VAL-083 is being studied in two collaborator-supported,
biomarker-driven Phase 2 clinical trials for MGMT-unmethylated GBM.
Overcoming MGMT-mediated resistance represents a significant unmet
medical need in the treatment of GBM.
Further information on DelMar's clinical trials can be found on
clinicaltrials.gov:
https://www.clinicaltrials.gov/ct2/results?cond=&term=val-083&cntry1=&state1=&recrs
For additional information, please visit
http://delmarpharma.com/; or contact DelMar Pharmaceuticals
Investor Relations: ir@delmarpharma.com / (604) 629-5989.
SAFE HARBOR STATEMENT
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995, including statements regarding the status of the
Company's clinical trials and the reporting of the
results. Any forward-looking statements contained herein are
based on current expectations but are subject to a number of risks
and uncertainties. The factors that could cause actual future
results to differ materially from current expectations include, but
are not limited to, risks and uncertainties relating to the
Company's ability to develop, market and sell products based on its
technology; the expected benefits and efficacy of the Company's
products and technology; the availability of substantial additional
funding for the Company to continue its operations and to conduct
research and development, clinical studies and future product
commercialization; and, the Company's business, research, product
development, regulatory approval, marketing and distribution plans
and strategies. These and other factors are identified and
described in more detail in the Company's filings with the SEC,
including the Company's Annual Report on Form 10-K for the year
ended June 30, 2019, the Company's
Quarterly Reports on Form 10-Q, and the Company's Current Reports
on Form 8-K.
CONTACTS:
Investors:
John Marco
Managing Director
CORE IR
516-222-2560
johnm@coreir.com
Media:
Jules
Abraham
Director of Public
Relations
CORE
IR
917-885-7378
julesa@coreir.com
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SOURCE DelMar Pharmaceuticals, Inc.